For helping to develop risk-based approaches to pharma quality
The US Food and Drug Administration (FDA) has awarded Peter Gough, partner at NSF-DBA, the FDA’s Leveraging/Collaboration Award for helping to develop risk-based approaches to pharmaceutical quality.
NSF-DBA, part of NSF International’s Health Sciences Division, has provided pharmaceutical, dietary supplement and medical device training, consultation and auditing services worldwide for more than 25 years.
Gough has more than 35 years’ experience in pharmaceutical manufacturing, control and quality management.
The FDA award recognises an individual or company’s efforts to collaborate with other government or industry groups to advance the FDA's public health mission.
Gough earned the award for participating in the Q9 Briefing Pack for the International Conference on Harmonisation (ICH Q9), which involved developing a structured approach to quality risk management for the pharmaceutical industry.
The ICH Q9 Risk Management outlines an agreed-upon process for pharmaceutical manufacturers and regulators and provides for common language. The three-stage risk management process addressed in ICH Q9 includes risk assessment, risk control and risk review.
Collectively ICH Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System provide a more structured way to define and control pharmaceutical products and their manufacturing process. All three are intended to work together to enhance pharmaceutical product quality. This enhanced approach is usually referred to as the Quality by Design approach.
‘Our collaborative and structural approach to risk management, product quality and regulatory mechanisms will benefit the entire pharmaceutical industry, regulators and, most important, patients by improving both quality and efficiency,’ said Gough. ‘It is an honour to receive the FDA’s Leveraging/Collaboration Award.’